Perimeter cut biopsy probe

ABSTRACT

A biopsy device having an insert is disclosed. The insert permits a user to obtain a tissue sample surrounding a center core(s) of removed tissue. The additional tissue provides an effective evaluation of whether all the desired tissue has been excised and a determination of whether an acceptable margin of healthy tissue has been removed.

FIELD OF THE INVENTION

The present invention relates generally to a perimeter cut biopsy probeand process, and more particularly pertains to a perimeter cut biopsyprobe and process.

BACKGROUND OF THE INVENTION

U.S. Pat. No. 6,086,544 discloses a MAMMOTOME® brand of surgical biopsydevice which is considered to be somewhat related to the presentinvention as the surgical biopsy device has a piercer having a piercertube with a tissue receiving side port located on the side of the distalend of the piercer tube for receiving tissue to be excised from asurgical patient. A tissue sample is drawn through the side port withthe assistance of a vacuum and a cutter is then actuated to sever thetissue sample. Accordingly, the side port can be utilized to take arotationally oriented tissue sample from the tissue surrounding thesurgical biopsy device by rotationally orienting the surgical biopsydevice with respect to the surrounding tissue of the surgical patient.

There are two primary approaches to removing tissue from a breast. Oneapproach removes the mass in one or two large pieces, and the otherapproach removes the mass in multiple pieces (minimum of three pieces).

Devices which may be suitable to remove the mass in a single piece aredisclosed in U.S. Pat. Nos. 6,077,231, 6,165,137 and 6,213,957, and inU.S. Pat. No. 6,080,113.

Devices intended to remove a mass in a single piece can include one ormore disadvantages. For instance, such devices can result in bleeding,and do not provide effective means (e.g. a vacuum to evacuate blood andother fluids from the site) to quickly and effectively manage bleedingas vessels are severed. Such devices may allow only a single cylinder oftissue to be excised from the breast. Moreover, due to the irregularmorphology of most breast cancers, it is often difficult to fullyencompass the lesion without utilizing an excessively large diametercutter.

Such devices may be used to remove an excised cylinder of tissue,however the excised tissue sample may not be oriented rotationally withrespect to the breast. Thus if additional tissue must be removed, thereis no indication of the orientation of the additional tissue withrespect to the breast. Such devices can also involve an excessive numberof procedural steps, requiring in excess of forty procedural steps.

SUMMARY OF THE INVENTION

The present invention provides a perimeter cut biopsy probe which allowsrotationally oriented perimeter specimens of tissue to be taken aroundthe perimeter of a core specimen of tissue after the core specimen oftissue has been taken and removed from a chamber in the biopsy probe.

In one embodiment, the invention provides a biopsy device comprising aprobe adapted for insertion into a tissue mass, the probe comprising asample port; a cutter disposed within the probe for removing a corespecimen of tissue; and an insert for placement within the probe, theinsert for providing a perimeter specimen of tissue.

A perimeter cut biopsy probe according to the present invention caninclude a biopsy probe housing having a cutter positioned therein whichis axially movable to remove specimens of tissue. The probe housing candefine at least one sample port through which a specimen of tissuesurrounding the probe is displaced into a specimen chamber. An insert,such as a shave insert, can be positionable within the probe housingafter an initial core tissue specimen has been taken and removed fromthe surgical site. At least one specimen chamber can be defined in theshave insert for receiving a perimeter specimen of tissue therein from aperimeter of the cavity of the initial core tissue specimen. Thespecimen chamber in the insert is aligned with the sample port, and thecutter is then actuated to cut a perimeter specimen of tissue in thespecimen chamber.

In greater detail, a vacuum passageway can be defined in the shaveinsert which couples a vacuum source to the specimen chamber to allowthe vacuum to pull tissue into the specimen chamber. A central,axially-extending vacuum passageway can be defined in the shave insertwhich communicates through vacuum ports with the specimen chamber.Alternatively, a vacuum lumen can be defined on a circumferentialportion of the distal end of the insert which communicates with thespecimen chamber by vacuum ports extending through a partitionseparating the specimen chamber from the vacuum lumen.

The perimeter cut biopsy probe can incorporate a tissue retraction armin the insert which is axially movable to stack previously-takenperimeter specimens of tissue in the probe housing in a locationproximal to the specimen chamber, to allow multiple perimeter slices tobe stacked within the probe housing after they are cut.

The perimeter cut biopsy probe can include an RF probe tip on the probehousing to aid tunneling and fine positioning of the probe with respectto tissue. Alternatively, an ultrasonically vibrating probe tip on theprobe housing can be used to aid tunneling and fine positioning of theprobe with respect to the tissue.

A tissue branding/cauterizing electrode on the probe housing enablesbranding/cauterizing of a specimen of tissue to preserve the rotationalorientation of the specimen of tissue relative to the tissue cavity.

The specimen chamber preferably has a size such that the perimeterspecimen thickness, width, and length fit into a standard cassette usedfor permanent sectioning during pathological evaluation.

The perimeter cut biopsy probe can incorporate a single sample portdefined in the probe housing. Alternatively, two sample ports can bedefined in the probe housing. The insert can define a single specimenchamber which is rotated to align with a sample port. Alternatively, theinsert can define two specimen chambers which are rotated to align withone or more sample ports.

In one embodiment wherein two sample ports are defined in the probehousing, a first insert defines a single specimen chamber which isrotated to align with either of the two sample ports to take a coretissue sample. A second perimeter insert is positioned in the probehousing after the first insert is removed, and the second perimeterinsert defines two perimeter specimen chambers which are aligned withthe two sample ports to take perimeter specimens of tissue.

The present invention also provides a procedure or process for operatinga perimeter cut biopsy probe which comprises positioning a housing ofthe perimeter cut biopsy probe in tissue of a surgical patient. At leastone initial core specimen of tissue is removed by displacing the corespecimen through at least one sample port in the probe housing, axiallytranslating a cutter from a recessed proximal position to a distalposition in the probe housing to cut the core specimen of tissue, andremoving the core tissue specimen from the probe housing. Then aperimeter shave insert is inserted within the probe housing, wherein theperimeter shave insert defines at least one perimeter specimen chamber.At least one perimeter specimen of tissue is removed from a perimeter ofthe cavity of the core tissue specimen, by aligning a perimeter specimenchamber in the insert with the sample port, displacing the perimeterspecimen of tissue through the sample port into the perimeter specimenchamber, and actuating the cutter from its recessed proximal position toits distal position to cut a perimeter specimen of tissue in thespecimen chamber.

In greater detail, tissue is pulled into the specimen chamber bycoupling a vacuum source to the specimen chamber. A tissue retractionarm can be moved axially to stack previously-taken perimeter specimensof tissue in the probe housing in a location proximal to the specimenchamber, to allow multiple perimeter specimens to be stacked within theprobe housing after they are cut. A specimen of tissue can bebranded/cauterized to preserve the rotational orientation of thespecimen of tissue relative the tissue cavity.

The insert, which can define a single specimen chamber, can be rotatedto align the single specimen chamber with a sample port in the probehousing. Alternatively, the insert can define two specimen chambers, andthe insert is rotated to align the two specimen chambers with one ormore sample ports in the probe housing.

In one process, a first insert defines a single specimen chamber and isrotated to align the single specimen chamber with one or more sampleports of the probe housing to take a core tissue sample, after which thefirst insert is removed and a second perimeter insert which defines twoperimeter specimens chambers is inserted into the probe housing. The twoperimeter specimen chambers are then aligned with the two sample portsto take first and second perimeter tissue specimens. After the first andsecond perimeter tissue specimens have been taken, the probe housing andthe second perimeter insert are rotated approximately 90 degrees, andthird and fourth perimeter tissue specimens, are taken, such that thefirst, second, third and fourth perimeter tissue specimens providespecimens with a contiguous 360 degree margin around the core tissuespecimen.

Although the disclosed embodiments of the present invention are forexcision and removal of cancerous lesions from breast tissue, thedisclosed embodiments should be considered as exemplary only, as theinvention also has applicability to the excision and removal of othertypes of tissue from other types of soft tissue such as the liver andthe lungs.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention for a perimeter cut biopsy probe may be morereadily understood by one skilled in the art with reference being madeto the following detailed description of several preferred embodimentsthereof, taken in conjunction with the accompanying drawings whereinlike elements are designated by identical reference numerals throughoutthe several views, and in which:

FIGS. 1, 2 and 3 are schematic illustrations of a simplified form of thepresent invention and show respectively, in FIG. 1 a perimeter cutbiopsy needle probe housing, in FIG. 2 the needle probe housing of FIG.1 having a perimeter shave insert inserted therein, and in FIG. 3 theneedle probe housing having a perimeter shave insert positioned therein,wherein the specimen chamber of the insert is aligned with the sampleport of the housing, and two already-removed perimeter specimens oftissue are temporarily stored in the proximal end of the probe housing.

FIG. 1 is a side elevational plan view of the distal end of a probewhich is employed by the perimeter cut biopsy device of the presentinvention without a perimeter shave insert positioned therein.

FIG. 1A is an axial sectional view of the probe of FIG. 1 taken alongsectional arrows 1A—1A in FIG. 1, and illustrates a vacuum lumen mountedexterior to and on one side of the substantially round profile of theprobe.

FIG. 2 is a side elevational plan view of the distal end of the probewith a perimeter shave insert pursuant to the present inventionpositioned and inserted therein in place of a knockout pin.

FIG. 2A is an axial sectional view of the probe of FIG. 2 taken alongsectional arrows 2A—2A in FIG. 2, and illustrates the perimeter shaveinsert pursuant to the present invention and a specimen chamber definedtherein.

FIG. 3 is a side elevational view, and FIG. 3A is an axial sectionalview of the probe of FIG. 3 taken along sectional arrows 3A—3A in FIG.3, with the perimeter shave insert pursuant to the present inventionhaving two preceding perimeter tissue slices positioned therein, andalso shows the specimen chamber therein.

FIG. 4 is an axial sectional view of tissue specimens which have beentaken by the probe, and shows a center core specimen, a 12 o'clockperimeter slice or shave, a 3 o'clock perimeter slice or shave, a 6o'clock perimeter slice or shave, and a 9 o'clock perimeter slice orshave.

FIG. 5 is a front perspective view of one embodiment of a large gaugeMAMMOTOME® perimeter cut biopsy probe of the prior art, which is usedwith the present invention, having a handpiece at a proximal end thereofand a probe tip at the distal end of the instrument, wherein thehandpiece has been removed therefrom.

FIGS. 6, 7, 8 and 8A are respectively first and second perspectiveviews, a longitudinal cross sectional view, and a radial cross sectionalview of a first embodiment of a needle probe housing which defines onesample port therein, wherein the probe structure of FIG. 6 is part ofthe prior art, and FIGS. 7, 8 and 8A show the contribution thereto of aperimeter shave insert pursuant to a first embodiment of the presentinvention.

FIG. 6 is a view of the distal end of the first embodiment of the probeouter housing, and illustrates an optional RF cutting/tunneling blade,vacuum openings, and a single sample notch port.

FIG. 7 is a view of the distal end of the probe wherein a firstembodiment of a perimeter shave insert pursuant to the present inventionand the cutter are visible through the sample notch port.

FIG. 8 is a longitudinal cross sectional view of the distal end of theprobe of FIG. 7, and illustrates the perimeter shave insert in itsdistal-most position, with a specimen chamber being aligned with thesample notch port and the cutter being in a retracted position, whereinthe perimeter shave insert is shown with a central, axially-extendingvacuum port communicating through vacuum ports with the specimen chamberand the vacuum ports in the probe housing.

FIG. 8A is an axial cross sectional view of the probe of FIG. 8 takenalong sectional arrows 8A—8A in FIG. 8.

FIGS. 9, 10, 11, 11A and 12 are respectively first and secondperspective views, a longitudinal cross sectional view, a radial crosssectional view, and third perspective view of a second embodiment of aneedle probe housing which defines two sample ports.

FIG. 9 illustrates a second embodiment of a needle probe housing havingan RF cutting tip and two sample notch ports.

FIG. 10 illustrates the probe housing of FIG. 9 having a core insert forremoval of a core of tissue placed therein, and also shows a cutterpositioned at the proximal ends of the ports.

FIG. 11 is a longitudinal cross sectional view of the probe of FIG. 10,and illustrates the core insert for removal of a core of tissue having avacuum lumen and vacuum ports defined in its lower portion.

FIG. 11A is an axial cross sectional view of the probe of FIG. 11 takenalong sectional arrows 11A—11A in FIG. 11.

FIGS. 12, 13 and 13A are respectively a perspective view, a longitudinalcross sectional view, and a radial cross sectional view, taken alongsectional arrows 13A—13A in FIG. 13, of the second embodiment of theneedle probe housing having two sample notch ports with a secondembodiment of a perimeter shave insert positioned therein which definestwo sample chambers.

FIG. 14 is a perspective view of an embodiment of a perimeter cut biopsyprobe pursuant the present invention wherein a perimeter shave insert isshown after its removal from the proximal end of a needle probe housing.

DETAILED DESCRIPTION OF THE DRAWINGS

Referring to the drawings in detail, FIGS. 1, 2 and 3 are schematicillustrations of simplified forms of the present invention. FIG. 1 showsonly a perimeter cut biopsy needle probe 10 having an outer housing 11.FIG. 2 illustrates the needle probe housing 11 of FIG. 1 having aperimeter shave insert 24 inserted therein. FIG. 3 shows the needleprobe housing 11 having the perimeter shave insert 24 positioned thereinwith the specimen chamber 33 of the insert aligned with the sample port18 of the housing, and two already-removed perimeter specimens of tissue34 temporarily stored in the proximal end of the needle probe housing11.

In greater detail, FIG. 1 is a side elevational view of the distal endof a probe 10 which is employed by the perimeter cut biopsy device ofthe present invention without a perimeter shave insert positionedtherein. The distal end of the needle probe housing 11 includes vacuumopenings 12, an optional tissue branding/cauterizing electrode 14, an RFcutting/tunneling tip 16, and a sample notch port 18.

FIG. 1A is an axial sectional view of the probe of FIG. 1 taken alongsectional arrows 1A—1A in FIG. 1, and illustrates an added vacuum lumen22 mounted exterior to and on one side of the substantially roundprofile of the probe 10.

FIG. 2 is a side elevational plan view of the distal end of the probewith a perimeter shave insert 24 pursuant to the present inventionpositioned and inserted therein in place of a knockout pin/core insertusually positioned therein, wherein a perimeter specimen chamber 33 ofthe shave insert 24 extends to a sample notch port 26, and a cutter 28is axially movable in the probe. Vacuum holes 30 are supplied with avacuum by an axial vacuum source through an attachment 32, and/or alateral vacuum source.

FIG. 2A is an axial sectional view of the probe of FIG. 2 taken alongsectional arrows 2A—2A in FIG. 2, and illustrates the perimeter shaveinsert 24 pursuant to the present invention which defines a specimenchamber 33 therein and the cutter 28 positioned in the probe forlongitudinal movement therein.

FIG. 3 is a side elevational view, and FIG. 3A is an axial sectionalview of the probe of FIG. 3 taken along sectional arrows 3A—3A in FIG.3, with the perimeter shave insert 24 pursuant to the present inventionhaving two preceding perimeter tissue 34 positioned therein, a specimenchamber 33, and an optional tissue retraction arm 36 which is axiallymovable to stack the preceding tissue slices 34.

FIG. 4 is an axial sectional view of both center core and perimetertissue specimens which have been taken by the probe, and show a centercore specimen 40, a 12 o'clock perimeter slice or shave 42, a 3 o'clockperimeter slice or shave 44, a 6 o'clock perimeter slice or shave 46,and a 9 o'clock perimeter slice or shave 48.

FIG. 5 is a front perspective view of one embodiment of a large gaugeMAMMOTOME® perimeter cut biopsy probe of the prior art, which is alsoused with the present invention, having a probe housing 11, a handpiece52 at a proximal end thereof, and a probe tip 16 at the distal end ofthe instrument, wherein the handpiece 52 has been removed therefrom.FIGS. 6, 7, 8 and 8A are respectively first and second perspectiveviews, a longitudinal cross sectional view, and a radial cross sectionalview of a first embodiment of a needle probe housing 11, which definesone sample port therein, wherein the probe structure of FIG. 6 is partof the prior art. FIGS. 7, 8 and 8A show the contribution thereto of afirst embodiment of a perimeter shave insert 24-1 pursuant to thepresent invention.

FIG. 6 is a perspective view of just the distal end of the firstembodiment of needle probe housing 11 with both the cutter 28 and thefirst embodiment of the perimeter shave insert 24-1 retracted therefrom,and illustrates an optional RF cutting/tunneling blade 16, vacuumopenings 12 through the needle probe housing 11, and a single samplenotch port 18 in the needle probe housing 11.

FIG. 7 is a perspective view of the distal end of the probe, and showsthe cutter 28 and the first embodiment of a perimeter shave insert 24-1positioned therein, having sidewalls 62, vacuum openings 30, and thespecimen chamber 33, which are visible through the sample notch port 18of the probe housing.

FIG. 8 is a longitudinal cross sectional view of the needle probe ofFIG. 7 taken along its longitudinal axis, and illustrates a bottomvacuum lumen 22, and a cross sectional view of the first embodiment ofthe perimeter shave insert 24-1, with the specimen chamber 33 beingaligned with the single sample notch port 18 and the cutter 28 being ina retracted proximal position, from which it is moved while rotating toan extended distal position to take a perimeter tissue slice 34. Theperimeter shave insert 24-1 has a central, axially-extending vacuum port64 communicating through the vacuum ports 30 with the specimen chamber33 and communicating through vacuum ports 35 with the vacuum ports 12 ofthe housing. FIG. 8 also illustrates the tissue retraction arm 36, andan electrical wire 29 extending through the bottom vacuum lumen to thedistal end of the probe where it extends through a radial aperture 31 toprovide RF electrical signals to the RF cutting/tunneling tip 16.

FIG. 8A is an axial cross sectional view of the probe of FIG. 8 takenalong sectional arrows 8A—8A in FIG. 8, and illustrates the specimenchamber 33, the bottom lumen 22, and the tissue retraction arm 36.

To reduce procedure time and possibly increase orientation accuracy,other embodiments of the probe, as illustrated by insert 24-3 in FIGS.12 and 13, can include two sample ports oriented 180 degrees apart. Theinsert 24-2 has two relief features corresponding to the two probeports. The advantages relative to a single-port shaver are a lower costneedle due to elimination of a vacuum lumen, and less procedural stepsare involved because the surgeon obtains two shaves with each passinstead of just one.

The two-opening design may offer more control over how the vacuumdisplaces tissue during the shaving steps. Because the vacuum is pullingthe tissue from opposite sides, a static tension is applied to thetissue 90 degrees offset from the bowls. The static tension reduces thepossibility of the vacuum pulling tissue into the probe that is notdirectly in front of the sample notch. This improves the chances ofcutting 360 degrees of contiguous tissue pieces so that the entiremargin around the initial core is removed.

These embodiments rotate the needle only once during the procedure toobtain four perimeter tissue samples, such that there is less potentialfor the outside of the needle to displace tissue unpredictably, againensuring that a complete margin is removed and that the orientation ofthe shaves is preserved for the pathologist.

FIGS. 9, 10, 11, and 11 A are respectively first and second perspectiveviews, a longitudinal cross sectional view, and an axial cross sectionalview of a second embodiment 70 of a needle probe which defines twosample ports 18-1, 18-2. The two sample port probe 70 has a hollowcylindrical probe/needle body 72 which has RF electrodes 16 at itsdistal end.

FIG. 9 illustrates just the probe needle housing 72 having an RF cuttingtip 16 and defining the two sample ports 18-1, 18-2. FIG. 10 illustratesthe probe housing of FIG. 9 having a core insert 24-2 for the removal ofa core tissue sample inserted therein, and also shows the cutter 28shown in a partially retracted position.

FIG. 11 is a longitudinal cross sectional view of the probe 70, andillustrates the core insert 24-2 having a vacuum lumen 22 defined in thelower portion of the insert, which communicates through vacuum ports 73with the specimen chamber 33 through a partition 74 separating thespecimen chamber 33 from the vacuum lumen 22. FIG. 11A is an axial crosssectional view further illustrating details of the probe and core insertof FIG. 11, including the core specimen chamber 33 and the vacuum lumen22.

FIGS. 12, 13 and 13A are respectively a perspective view, a longitudinalcross sectional view, and a radial cross sectional view, taken alongsectional arrows 13A—13A in FIG. 13, of an embodiment of a probe 80including the second embodiment of the needle probe 72 with two samplenotch ports and further having a second embodiment of a perimeter shaveinsert 24-3 inserted therein to remove margin specimens of tissue afterthe core insert 24-2 has been used to remove an initial core tissuesample. The perimeter shave insert 24-3 has a central axially-extendingvacuum lumen 82 which communicates through radially extending vacuumports 84 with first and second radially-opposed and symmetrical specimenchambers 33-1, 33-2, such that two perimeter tissue specimens 34 can betaken at one time. One advantage of this embodiment is that the twovacuum forces on opposite sides of the probe counterbalance each other.The probe housing 72 and insert can then be rotated 90 degrees and thenext two shaves of perimeter tissue can be taken through specimenchambers 33-1 and 33-2 of the probe housing. These four shaves provide acontiguous 360 degrees margin of tissue around the initial core tissuesample, as illustrated in FIG. 4.

FIG. 14 is a perspective view of an embodiment of a perimeter cut biopsyprobe pursuant the present invention wherein a perimeter shave insert24-4, having a vacuum connection fitting 88, is shown after its removalfrom the proximal end of a needle probe housing 11. As illustratedbroadly in FIG. 14, the perimeter shave insert is inserted and removedlongitudinally through the proximal end of the needle probe housing. Thecore insert is inserted and removed longitudinally through the proximalend of the needle probe housing in a similar manner.

The present invention provides a perimeter cut biopsy probe whichincludes an insert to excise tissue surrounding a center core(s) ofremoved tissue. The additional tissue provides an effective evaluationof whether all the desired tissue has been excised and of whether anacceptable margin of healthy tissue has been removed.

Compared to today's typical lumpectomy procedure/technique (needlelocalization followed by a lumpectomy where a scissors, scalpel, ormonopolar pencil is used to dissect the tissue), the perimeter cutbiopsy probe of the present invention more efficiently removes tissue(i.e. removes only desired/required tissue) resulting in reduced breastdimpling or better cosmesis. It also reduces the length of the incision.

The perimeter cut biopsy probe of the present invention provides alumpectomy device that is compatible with imaging systems involvingbreast compression/immobilization and stereotactic localization (e.g.Mammography, MRI, PET). The subject invention also reduces or eliminatessteps in the care pathway of a lumpectomy procedure (e.g. eliminateswire localization procedure), and reduces the current re-excision ratewhich is (20–50%) resulting from inadequate margins.

The perimeter cut biopsy probe of the present invention improves theaccuracy of processing and analysis of the lumpectomy specimen bypathology, and maintains or improves the ability of the surgeon todetermine the orientation of the tissue as it was excised in the breast.

The perimeter cut biopsy device of the present invention employsconventional MAMMOTOME® features (vacuum assist, lateral sample bowl,rotating and translating circular cutter), as described for instance inU.S. Pat. Nos. 5,526,822, 5,769,086, 5,775,333, 5,980,469 and 6,086,544,which patents are incorporated herein by reference. An insert locatedwithin the cutter replaces the knock-out pin after the initial centercore(s) of tissue is removed. The insert is designed to remove slices oftissue located at the perimeter of the initial cavity to aid in margindeterminations. It utilizes vacuum to pull tissue into the bowl. Theperimeter slices are removed individually similar to the currentMammotome® device.

Optional features allow multiple perimeter slices to be stacked withinthe probe/cutter as they are cut. To remove the stacked slices, theinsert is removed from the probe. The order of excision and orientationof the slices is preserved. Also, by stacking the slices the overallprocedure time is reduced. To orient the cylindrical center core(s), aportion of the core can be cauterized to record and preserve therotational orientation of the core. The probe tip can be designed tofacilitate tunneling and maneuvering of the probe, to result in reducedbleeding along the tunneling path. RF (monopolar or bipolar) andultrasonic (e.g. Ultracision™) are two potential approaches. Holes orports can be located in the probe and the cutter. When the cutter is atspecific positions, these holes are aligned to allow fluid to becommunicated from within the cutter to the outside perimeter of theprobe. This allows, for example, epinephrine to be injected through thevacuum tubing into the probe and into the tissue surrounding the probeto manage bleeding.

SUMMARY OF PROCEDURAL STEPS

Energy assistance (e.g. RF, ultrasonic) located at the probe tip is usedto tunnel to the suspicious mass while using Ultrasound, X-Ray, MRI, orPET imaging. This could potentially occur without the aid of a needlelocalization wire. In the case of a mass, the intent is to tunnel alongthe outer edge of the mass, although the probe could also be insertedthrough the mass.

With the lesion adjacent to the sample bowl in the probe tip, largecylindrical core or cores of tissue are taken, similar to the currentbiopsy procedure. Based on a gross examination of the large tissue core,if it is believed that a majority of the lesion has been removed, theprobe is left in place, and the knock-out pin is replaced with a shavinginsert. Based on imaging or gross examination, if it is believed that alarge portion of the mass remains in the breast, another large core oftissue could be removed.

With the shaving insert inserted into the probe, a series of perimeterslices of tissue are dissected as the probe is rotated about itslongitudinal axis. The perimeter slices are sequentially stacked withinthe probe. When a sufficient number of perimeter slices has beendissected, the insert subassembly is removed from the probe, to allowthe perimeter slices to be removed from the insert subassembly. Based onimaging or gross examination of the perimeter slices, it is possible toremove tissue beyond the initial 360 degree sampling pass.

With the tissue removed from the body, the core tissue and the perimeterslices can be reoriented with respect to each other and to the cavityfor inspection and analysis by the surgeon, radiologist and/orpathologist. The perimeter slices are preferably intended to fit into aconventional permanent-sectioning cassette utilized in pathology. Basedon real-time palpation, visualization, and other means (e.g. frozensections, X-Ray, optical diagnostic scanning devices, etc.), additionaltissue can be excised in a specific area of the cavity based on thereal-time evaluation of the excised tissue and the specific orientationof the specimen.

An alternate embodiment can be used to acquire a single piece marginspecimen, in which a non-cylindrical, non-rotating cutter can beutilized. The device employs a similar insert, however, an arcuatecutter cuts a portion of the circumference while advancing.Sequentially, the device is rotated and the cutter severs the nextportion of the tissue margin. Once the device has been rotated aroundthe entire circumference, a single piece margin is obtained. The cuttingmechanism for this device also preferably employs an energy source (e.g.RF, ultrasonic, etc.).

A preferred embodiment of the present invention includes an RF (mono orbipolar) probe tip to aid tunneling and fine positioning of the probewith respect to the tissue/lesion. An RF probe tip should theoreticallyallow a blunter probe to improve access near the chest wall, and tocauterize tissue (i.e. reduce bleeding) while tunneling. An alternativeembodiment can incorporate a passive sharp metal tip in a razor bladetype of design. The cylindrical center core(s) is preferably marked asby cauterizing/branding, as shown in FIG. 1, to orient it relative tothe perimeter slices and the tissue cavity. A port can be provided onthe external surface of the needle probe to allow a vacuum orepinephrine to be applied to tissue surrounding the probe to managebleeding. The perimeter slice thickness, width, and length are designedto fit into a standard cassette used for permanent sectioning duringpathological evaluation.

While several embodiments and variations of the present invention for aperimeter cut biopsy probe are described in detail herein, it should beapparent that the disclosure and teachings of the present invention willsuggest many alternative designs to those skilled in the art.

1. An apparatus for performing a biopsy, the apparatus comprising: aprobe adapted for insertion into a tissue mass, the probe comprising asample port; a cutter disposed within the probe for removing a corespecimen of tissue; and an insert for placement within the probe, theinsert for providing a perimeter specimen of tissue; and wherein theinsert comprises at least two specimen chambers.
 2. The apparatus ofclaim 1 wherein the probe comprises at least two sample ports.
 3. Theapparatus of claim 1 wherein the cutter is hollow.
 4. The apparatus ofclaim 3 wherein the cutter is adapted to advance axially over at least aportion of the insert to sever tissue drawn through the sample port. 5.The apparatus of claim 4 wherein the cutter is adapted to rotate whileadvancing axially.
 6. The apparatus of claim 1 further comprising avacuum source in flow communication with the sample port.
 7. Theapparatus of claim 1 wherein the insert comprises a vacuum passageway inflow communication with a vacuum source.
 8. The apparatus of claim 1wherein the probe comprises a distal end for piercing tissue.
 9. Aperimeter cut biopsy probe comprising: a biopsy probe housing having acutter positioned therein which is axially movable in the probe housingto remove specimens of tissue, and for removing at least one initialcore specimen of tissue, the probe housing defining at least one sampleport through which a specimen of tissue surrounding the probe isdisplaced into a specimen chamber, and wherein the cutter is thenaxially translated from a recessed proximal position to a distalposition in the probe housing to out the core specimen of tissue; atleast one shave insert adapted to be positioned within the probe housingafter the initial core tissue specimen is removed, and at least onespecimen chamber defined in the shave insert for receiving a perimeterspecimen of tissue therein from a perimeter of a cavity of the initialcore tissue specimen, wherein the insert is positioned in the probehousing with a specimen chamber in the insert aligned with a sampleport, and the cutter is then actuated to cut a perimeter specimen oftissue in the specimen chamber; and wherein a vacuum lumen is defined ona circumferential portion of the shave insert which communicates withthe specimen chamber by vacuum ports extending through a partitionseparating the specimen chamber from the vacuum lumen.
 10. The perimetercut biopsy probe of claim 9, including a vacuum passageway defined inthe shave insert which couples a vacuum source to the specimen chamberto allow the vacuum to draw tissue into the specimen chamber.
 11. Theperimeter cut biopsy probe of claim 9, including a central,axially-extending vacuum passageway defined in the shave insert whichcommunicates through vacuum ports with the specimen chamber.
 12. Theperimeter cut biopsy probe of claim 9, including a tissue retraction armin the insert which is axially movable to stack previously-takenperimeter, specimens of tissue.
 13. The perimeter cut biopsy probe ofclaim 12 wherein the tissue retraction arm is axially movable to stackpreviously-taken perimeter specimens of tissue in the probe housing in alocation proximal to the specimen chamber, to allow multiple perimeterslices to be stacked within the probe housing after they are cut. 14.The perimeter cut biopsy probe of claim 9 further comprising an RF probetip on the probe housing to aid tunneling and fine positioning of theprobe with respect to tissue.
 15. The perimeter cut biopsy probe ofclaim 9 further comprising a tissue cauterizing electrode on the probehousing to mark a specimen of tissue to preserve the rotationalorientation of the specimen of tissue relative to a tissue cavity. 16.The perimeter cut biopsy probe of claim 9, wherein the probe housingcomprises two sample ports.
 17. The perimeter cut biopsy probe of claim16 wherein the insert comprises two specimen chambers.